Major u-turn sees Roche’s Kadcyla backed for NHS use

In a major turnaround Roche’s Kadcyla will now become routinely available on the NHS to some patients with breast cancer after a confidential deal was reached between the drug giant and NHS England.

Kadcyla (trastuzumab emtansine), which costs £90,000 per patient without discount, offers on average around six months of extended life and a more tolerable safety profile than existing treatments.

The drug had been available to patients in England via the Cancer Drugs Fund, but NICE has now published final guidance approving mainstream funding for women with HER2-positive breast cancer which is inoperable, advanced, or has spread to other parts of the body and who have previously received Herceptin (trastuzumab) and a taxane, separately or in combination.

Patients should have either received prior therapy for locally advanced or metastatic disease or developed disease recurrence during or within six months of completing adjuvant therapy if they are to be considered for treatment with Kadcyla.

Roche says the decision ends four years of inequality of access across the UK, bringing the country in line with Scotland and 15 other countries across the European Union where the drug is already available.

After Kadcyla’s provisional rejection by NICE on 29 December 2016, Breast Cancer Now launched an urgent petition to overturn this draft decision to both Sir Andrew Dillon, chief executive at NICE, and Richard Erwin, general manager at Roche Products. In less than one month, the petition amassed over 115,000 signatures from across the country.

“This is exceptionally good news for so many breast cancer patients,” Baroness Delyth Morgan, chief executive at Breast Cancer Now. “We are absolutely delighted that tough negotiation and flexibility by NICE and NHS England, and the willingness of Roche to compromise on price, have ensured that thousands of women with incurable breast cancer will be given precious time to live."

“This outcome also demonstrates vital signs of life for the drug appraisal system in this country,” she added. The “landmark decision bodes well for patients looking for reassurances that modern cancer treatments can get through to NHS patients more quickly and can bring transformational improvements in patient outcomes for the future.”

NHS England chief executive Simon Stevens said the decision on Kadcyla “shows that for companies who are willing to work with us, there are concrete gains for them, for the NHS and most importantly for patients able to get new and innovative drugs. In this case, tough negotiation and flexibility between the NHS and Roche means both patients and taxpayers are getting a good deal.”

Around 1,200 women with incurable secondary breast cancer will be eligible to receive Kadcyla in England each year.